A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)

Who is this study for? Patients with Lymphoma
What treatments are being studied? Zandelisib (ME-401)
Status: Recruiting
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme

• Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or

• Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL

• Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL

• Age ≥ 18

• At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification

• Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment

• QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);

• Left ventricular ejection fraction (LVEF) ≥ 45%

Locations
United States
Arizona
Oncology Institute of Hope and Innovation
Recruiting
Tucson
California
Pacific Cancer Medical Center, Inc.
Recruiting
Anaheim
Tower Hematology Oncology
Recruiting
Beverly Hills
The Oncology Institute of Hope and Innovation
Recruiting
Downey
Sharp Memorial Hospital
Recruiting
San Diego
Florida
H. Lee Moffit Cancer Center
Recruiting
Tampa
Cleveland Clinic-Florida
Recruiting
Weston
Illinois
Rush University Medical Center
Recruiting
Chicago
Advocate Health & Hospitals Corporation
Recruiting
Niles
Indiana
Investigative Clinical Research of Indiana LLC
Recruiting
Indianapolis
Massachusetts
Dana-Farber Cancer Institute
Recruiting
Boston
Michigan
University of Michigan Medical School
Recruiting
Ann Arbor
Montana
St. Vincent Frontier Cancer Center
Recruiting
Billings
North Carolina
Duke Cancer Center
Recruiting
Durham
New Jersey
Memorial Sloan Kettering
Recruiting
Basking Ridge
Memorial Sloan Kettering
Recruiting
Middletown
Memorial Sloan Kettering
Recruiting
Montvale
New Mexico
San Juan Oncology
Recruiting
Farmington
Nevada
The Oncology Institute of Hope and Innovation
Recruiting
Henderson
New York
Memorial Sloan Kettering
Recruiting
Commack
Memorial Sloan Kettering
Recruiting
Harrison
Clinical Research Alliance
Recruiting
Lake Success
Memorial Sloan Kettering
Recruiting
New York
Stony Brook University
Withdrawn
Stony Brook
Memorial Sloan Kettering
Recruiting
Uniondale
Ohio
Cleveland Clinic
Recruiting
Cleveland
Oregon
Oregon Health and Science University
Recruiting
Portland
Tennessee
Vanderbilt University
Recruiting
Nashville
Texas
Renovatio Clinical
Recruiting
Houston
Washington
Swedish Cancer Institute
Recruiting
Edmonds
Swedish Cancer Institute
Recruiting
Seattle
Medical Oncology Associates PS
Recruiting
Spokane
Northwest Medical Specialties
Withdrawn
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center
Recruiting
Marshfield
Other Locations
Australia
Peninsula and South Eastern Haematology and Oncology Group
Recruiting
Frankston
Liverpool Hospital
Recruiting
Sydney
The Perth Blood Institute
Recruiting
West Perth
Austria
Kepler Universitatsklinikum GmBH
Recruiting
Linz
Medical University of Vienna
Recruiting
Vienna
Belgium
AZ Sint-Jan Brugge-Oostende
Recruiting
Brugge
Cliniques Universitaires Saint-Luc
Recruiting
Brussels
Institut Jules Bordet
Recruiting
Brussels
Antwerp University Hospital
Recruiting
Edegem
France
C H de la Cote Basque, Service d'Hematologie
Recruiting
Bayonne
CHD Vendee, Onco-hematologie
Recruiting
La Roche-sur-yon Cedex 9
Centre Hospitalier du Mans
Recruiting
Le Mans
Centre Hospitalier de Mulhouse
Recruiting
Mulhouse
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
Recruiting
Poitiers
Institut Gustave Roussy
Recruiting
Villejuif
Germany
Universitatsklinikum Halle
Recruiting
Halle
Munich Municipal Hospital
Recruiting
Munich
Universitatsklinikum Munster
Recruiting
Münster
Hamatologisch-Onkolgische Praxis
Recruiting
Nordheim
Klinikum Mutterhaus Feldstr
Recruiting
Trier
Universitatsklinikum Ulm
Recruiting
Ulm
Italy
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Recruiting
Aviano
Policlinico Sant'Orsola Malpighi
Recruiting
Bologna
IRCCS AOU Policlinico San Martino
Recruiting
Genova
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
Recruiting
Meldola
UOC Oncoematologia
Recruiting
Napoli
Ospedale Santa Maria delle Croci
Recruiting
Ravenna
Infermi Hospital Rimini
Recruiting
Rimini
Universita Cattolica del Sacro Cuore
Recruiting
Roma
IRCCS Regina Elena National Cancer Institute
Recruiting
Rome
Azienda Ospedaliera Santa Maria
Recruiting
Terni
Ospedale DellAngelo Di Mestre Umberto I
Recruiting
Venice
New Zealand
North Shore Hospital
Recruiting
Auckland
Southern District Hospital
Recruiting
Dunedin
Poland
Szpital Uniwersytecki nr 2 im.
Recruiting
Bydgoszcz
Pratia MCM Krakow
Recruiting
Kraków
ojewodzkie Wielospecjalistyczne Centrum
Recruiting
Łódź
Instytut Hematologii i Transfuzjologii
Recruiting
Warszawa
Primary Specialty Oncology
Recruiting
Warszawa
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Recruiting
Wroclaw
Republic of Korea
Dong-A University Hospital
Recruiting
Busan
Pusan National University Hospital
Recruiting
Busan
Asan Medical Center
Recruiting
Seoul
Ewha Womans University Mokdong Hospital
Recruiting
Seoul
Korea University Anam Hospital
Recruiting
Seoul
Samsung Medical Center
Recruiting
Seoul
Seoul National University Hospital
Recruiting
Seoul
The Catholic University of Korea-Seoul St. Marys Hospital
Recruiting
Seoul
Ulsan University Hospital
Recruiting
Ulsan
Spain
Hospital Universitari Mutua Terrasa
Recruiting
Barcelona
Hospital Universitari Vall d'Hebron
Recruiting
Barcelona
ICO-Hospital Duran i Reynals
Recruiting
Barcelona
Hospital Universitario de Canarias
Recruiting
La Laguna
Fundacion Jimenez Diaz
Recruiting
Madrid
Hospital Universitario Quiron Salud Madrid
Recruiting
Madrid
Hospital Universitario Ramon y Cajal
Recruiting
Madrid
MD Anderson Cancer Center
Recruiting
Madrid
Complejo Hospitalario de Navarra
Recruiting
Pamplona
Hospital Clinico de Salamanca
Recruiting
Salamanca
Hospital Universitario Virgen Macarena
Recruiting
Sevilla
Hospital Virgen del Rocio
Recruiting
Sevilla
Miguel Servet Hospital
Recruiting
Zaragoza
Switzerland
Ente Ospedaliero Cantonale (EOC)
Recruiting
Bellinzona
Taiwan
China Medical University Hospital
Recruiting
Taichung
Chi-Mei Medical Center, Liouying
Recruiting
Tainan
National Cheng Kung University Hospital
Recruiting
Tainan City
National Taiwan University Hospital NTUH
Recruiting
Taipei City
United Kingdom
Belfast Health and Social Care Trust - Belfast City Hospital
Recruiting
Belfast
Royal Cornwall Hospital
Recruiting
Cornwell
e Clatterbridge Cancer Centre
Recruiting
Liverpool
Royal Liverpool University Hospital
Recruiting
Liverpool
Centre for Haematology, Imperial College London
Recruiting
London
Lewisham and Greenwich University Hospital Lewisham
Recruiting
London
Royal Marsden Hospital
Recruiting
London
St George's Hospital
Recruiting
London
The Christie NHS Foundation Trust
Recruiting
Manchester
Norfolk and Norwich University Hospital NHS Foundation Trust
Recruiting
Norwich
Nottingham University Hospital
Recruiting
Nottingham
Oxford University Hospitals
Recruiting
Oxford
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Recruiting
Rhyl
Royal Hallamshire Hospital
Recruiting
Sheffield
Contact Information
Primary
MEI Pharma MEI Pharma
Patients@meipharma.com
858-369-7100
Time Frame
Start Date: June 25, 2019
Estimated Completion Date: April 2025
Participants
Target number of participants: 180
Treatments
Experimental: Zandelisib (ME-401) open label
Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Sponsors
Leads: MEI Pharma, Inc.

This content was sourced from clinicaltrials.gov

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